The Director-General of the American "Pfizer" Albert Burla announced Tuesday that the pharmaceutical group will submit "very soon" an application for a license to market its new anti-corona virus vaccine in the United States, which will allow the start of vaccination operations during December. An emergency license is a temporary or conditional authorization granted by the US Medicines Agency to respond to an emergency similar to the COVID-19 pandemic. </p><div> <p>Announced the general manager <a target="_blank" href="https://www.france24.com/ar/أمريكا/20201109-فايزر-و-بايونتيك-التجارب-السريرية-تظهر-أن-لقاحنا-ضد-فيروس-كورونا-فعال-بنسبة-90" rel="noopener noreferrer"><strong>For "Pfizer"</strong></a> Albert Burla Tuesday that the American pharmaceutical group will submit "very soon" an "urgent" request for a license to market its COVID-19 vaccine (which it developed in cooperation with the German company Biontech) in the United States, which will allow the vaccination operations to start in December.
Burla said, “We are very close to submitting an emergency license application,” but he did not confirm or deny whether the application will be submitted this week, noting that he previously said that the application will likely be submitted in the third week of November.
An emergency license is a temporary or conditional authorization granted by the US Medicines Agency (FDA) to respond to an emergency similar to the COVID-19 pandemic. The agency can revoke or amend this authorization if new data on the effectiveness or safety of the vaccine emerge later.
The US Food and Drug Administration did not say how long it would take to review data on the effectiveness and safety of the vaccine, which are the two main criteria for issuing an emergency license for it, in addition to the ability to produce large doses of it.
In Europe, the Medicines Agency uses an expedited procedure that allows it to conduct a “continuous assessment” of data on the efficacy and safety of any vaccine or drug as soon as these data are released and even before the manufacturer submits an official license application.
And the Pfizer vaccine is one Three experimental vaccines The European Medicines Agency is following up the progress of clinical trials on it according to the expedited mechanism. The other two vaccines were developed, one Oxford / AstraZeneca and the other Moderna.
France 24 / AFP